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The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531606
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Kye Bong-Hyeon, The Catholic University of Korea

Tracking Information
First Submitted Date  ICMJE April 15, 2018
First Posted Date  ICMJE May 22, 2018
Last Update Posted Date July 18, 2018
Actual Study Start Date  ICMJE December 12, 2016
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Anterior resection syndrome improvement change [ Time Frame: 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery ]
3 times performed through questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03531606 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • Bowel examination [ Time Frame: 4 weeks after surgery, 5 weeks after surgery ]
    2 times performed through questionnaire
  • Quality of Life of Cancer Patients(EORTC QLQ-C30) [ Time Frame: 1 week before surgery, 4 weeks after surgery ]
    2 times performed through questionnaire
  • Markers related Inflammation [ Time Frame: 1 week before surgery, 4 weeks after surgery ]
    WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio
  • NSI(Nutritional Screening Index) [ Time Frame: 1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery ]
    PG-SGA: Patient-Generated Subjective Global Assessment
  • Clavien-Dindo Classification [ Time Frame: 1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery ]
    Assessment through "Clavien-Dindo Classification"
  • NGS, SCFA [ Time Frame: 1 week before surgery, 1 week after surgery, 4 weeks after surgery, 5 weeks after surgery ]
    NGS(New Generation Sequencing), SCFA(Short-Chain Fatty Acid)
  • Other biomarkers [ Time Frame: 1 week before surgery, 4 weeks after surgery ]
    Zonulin, other Cytokines
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome
Official Title  ICMJE The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome After Anterior Resection of Colon Cancer; Double-blind, Randomized, Placebo-controlled Trial
Brief Summary The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among the symptom (s) of anterior resection syndrome that may occur after surgery in patients for efficacy and safety in Metchnik probiotic ingestion.
Detailed Description The purpose of the clinical trial is to evaluate the efficacy and safety of the syndrome that may occur after colon cancer surgery, To evaluate the efficacy and safety of the improvement effect of the defecatory activity on the improvement of the Medienkov probiotics biotics on the patients who have the deficit function and planned to surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study has been designed for randomized, double Blinded, placebo clinical trial.
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Sigmoid Colon Cancer
Intervention  ICMJE
  • Drug: Mechnicov probiotics

    Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.

    The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.

    (1 week before surgery and 3 weeks after surgery)

    The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'

    Other Name: Anterior resection
  • Drug: Placebo

    Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.

    The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.

    (1 week before surgery and 3 weeks after surgery)

    The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'

    Other Name: Anterior resection
Study Arms  ICMJE
  • Experimental: Experimental

    Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.

    The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.

    (1 week before surgery and 3 weeks after surgery)

    The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'

    Intervention: Drug: Mechnicov probiotics
  • Placebo Comparator: Placebo comparator

    Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.

    The patients enrolled into placebo comparator group will take one pack of 'Placebo' which is composed of lactose and simulates a 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.

    (1 week before surgery and 3 weeks after surgery)

    The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2018)
68
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult male or female aged 20 to over 75 years old
  2. As histologically and radiologically diagnosed S colon cancer, those who is scheduled for anterior resection
  3. Those who have been agreed to participate in this trial (through Informed consent) before initiation of clinical trial.

Exclusion Criteria:

  1. Those who have metastatic colorectal cancer screening
  2. Those who have urinary incontinence or fecal incontinence
  3. Those who received preoperative chemotherapy or radiotherapy
  4. Those who have a history of severe cerebral vascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe cardiac disease (unstable angina pectoris, myocardial infarction, arrhythmia requiring heart failure heart failure therapy)
  5. Those who have neurologist or psychologically important psychiatric history or current disease
  6. Those who have alcohol addiction, substance abuse
  7. Those who have Immune system, infectious infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease)
  8. Those who have uncontrolled hypertension, diabetes patients
  9. Those who have creatinine with more than twice from normal upper limit in site
  10. Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site
  11. Those who have probiotics, antibiotics, continually within the last one week
  12. Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice
  13. Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial
  14. under the investigator's judgment, those who is not qualified to participate this clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03531606
Other Study ID Numbers  ICMJE KY_Mpro3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kye Bong-Hyeon, The Catholic University of Korea
Study Sponsor  ICMJE Kye Bong-Hyeon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: SungSik Jang, Ph.D R &D
PRS Account The Catholic University of Korea
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP